Tissue puncture closure device with magazine fed tamping system

ABSTRACT

The present invention is directed to methods and apparatus for sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being with an anchor, a sealing plug and a filament connecting the anchor and sealing plug. The method and apparatus provide a magazine fed tamping system for automatic tamping and/or cinching of the sealing plug when the apparatus is withdrawn from the puncture site. The automatic tamping and/or cinching is facilitated by transducing a motive force generated by the withdrawal of the apparatus into a tamping and/or cinching force.

FIELD OF THE INVENTION

This invention relates generally to medical devices and moreparticularly to devices for sealing punctures or incisions in a tissuewall.

BACKGROUND

Various surgical procedures are routinely carried out intravascularly orintraluminally. For example, in the treatment of vascular disease, suchas arteriosclerosis, it is a common practice to invade the artery andinsert an instrument (e.g., a balloon or other type of catheter) tocarry out a procedure within the artery. Such procedures usually involvethe percutaneous puncture of the artery so that an insertion sheath canbe placed in the artery and thereafter instruments (e.g., catheter) canpass through the sheath and to an operative position within the artery.Intravascular and intraluminal procedures unavoidably present theproblem of stopping the bleeding at the percutaneous puncture after theprocedure has been completed and after the instruments (and anyinsertion sheaths used therewith) have been removed. Bleeding frompuncture sites, particularly in the case of femoral arterial punctures,is typically stopped by utilizing vascular closure devices, such asthose described in U.S. Pat. Nos. 6,179,963; 6,090,130; and 6,045,569and related patents that are hereby incorporated by reference.

Typical closure devices such as the ones described in theabove-mentioned patents place a sealing plug at the tissue puncturesite. Successful deployment of the sealing plug, however, requires thatit be manually ejected from within a device sheath and tamped down to anouter surface of the tissue puncture using a tamping tube. The tampingprocedure cannot commence until the device sheath (within which thetamping tube is located) has been removed so as to expose the tampingtube for manual grasping. Under certain conditions, removal of thesheath prior to tamping the sealing plug may cause the sealing plugitself to be retracted from the tissue puncture, hindering subsequentplacement of the sealing plug, and resulting in only a partial seal andassociated late bleeding from the tissue puncture. Accordingly, there isa need for improving the mechanism for deployment of the sealing plug atthe site of a tissue puncture.

SUMMARY

The present invention meets the above-described needs and others.Specifically, the present invention provides methods and systems forclosing internal tissue punctures. However, unlike prior systems, thepresent invention provides automatic tamping to a sealing plug as theclosure device is retracted. In addition, the present invention allowsthe automatic tamping system to receive a plurality of tamping devicesarranged in a magazine that cooperate to form a longer tamping device.

In one of many possible embodiments, the present invention provides aninternal tissue puncture closure device. The device comprises a filamentextending from a first end of the closure device to a second end of theclosure device, an anchor for insertion through the tissue wall punctureattached to the filament at the second end of the closure device, asealing plug slidingly attached to the filament adjacent to the anchor,and a driving mechanism for tamping the sealing plug toward the secondend. The driving mechanism comprises a magazine housing a plurality ofseparate tamping devices. The plurality of separate tamping devices mayeach comprise a rack. The magazine may include a biasing member, and theplurality of separate tamping devices may be stacked in the magazine andbiased in a first direction by the biasing member. The driving mechanismalso comprises a transducer capable of effecting a distal force on oneor more of the plurality of separate tamping devices upon withdrawal ofat least a portion of the closure device from a tissue puncture. Thetransducer may comprise a first gear and spool assembly with a portionof the filament wound on the spool, such that one or more of theplurality of tamping devices is directly or indirectly driven by thefirst gear. The first gear and spool assembly may be disposed on acommon axis and interconnected, and the transducer may include a secondgear meshed with the first gear. One or more of the plurality of tampingdevices may be directly driven linearly by the second gear. A third gearmay also be meshed with the first gear. Accordingly, one or more of theplurality of tamping devices may be directly driven linearly by thesecond and third gears. One or more of the plurality of tamping devicesmay abut and drive a tamping tube and the sealing plug toward theanchor.

According to some embodiments, the transducer includes a first gear andspool assembly with a portion of the filament wound upon the spool, thefirst gear and spool assembly disposed on a common axis andinterconnected, a magazine feed gear meshed with the first gear, and atamper gear meshed with the first gear, where one or more of theplurality of tamping devices is fed by the magazine feed gear to thetamper gear and driven by the tamper gear to tamp the sealing plugtoward the anchor.

According to some aspects of the invention, the driving mechanismcomprises an automatic driving mechanism. The plurality of tampingdevices may be driven by the automatic driving mechanism in response toretraction of the closure device, and a tamping tube is driven by theplurality of tamping devices to tamp the sealing plug. The drivingmechanism may comprise a transducer for effecting a tamping force on thesealing plug upon withdrawal of the closure device from the tissue wallpuncture. As mentioned above, the transducer may include a first gearand spool assembly with a portion of the filament wound thereon, and oneor more of the plurality of tamping devices may be directly orindirectly driven by the first gear. The spool may rotate and drive thefirst gear in a first direction, and the first gear may drive one ormore of the plurality of tamping devices in a second direction, when theanchor is deployed and the closure device is retracted from the tissuewall puncture.

Another aspect of the invention provides a tissue puncture closuredevice for partial insertion into and sealing of a tissue puncture in aninternal tissue wall accessible through a percutaneous incision. Thedevice comprises a handle portion, a carrier tube extending from thehandle portion, a filament extending from the handle portion and throughthe carrier tube, a sealing plug disposed on the filament, a gear trainhoused in the handle portion, a spool operatively connected to the geartrain with a portion of the filament wound on the spool, and a magazinefed tamping device operatively connected to the gear train. The magazinefed tamping device may comprise a spring loaded set of stacked racksengageable with the gear train. The gear train may comprise a mastergear, and two slave gears each meshed with the master gear. Theapparatus may further comprise an anchor attached to the filament at adistal end of the carrier tube, where the filament unwinds from thespool and drives the gear train in response to retraction of the handleportion from the tissue puncture if the anchor is deployed therein. Thegear train may automatically drive the magazine fed tamping device, andthe magazine fed tamping device tamps the sealing plug toward theanchor.

Another aspect of the invention provides a method of sealing a tissuepuncture in an internal tissue wall accessible through a percutaneousincision. The method comprises withdrawing a closure device from thetissue puncture, feeding a tamping device stack to a tranducer, andautomatically transducing a motive force generated by withdrawal of theclosure device in a first direction to a tamping force on the tampingdevice stack in a second direction. The feeding may further comprisebiasing the tamping device stack with a spring in a magazine housing thetamping device stack. The method may further comprise applying thetamping force in the second direction to a sealing plug. The method mayfurther comprise transferring the motive force to one or more tampingdevices of the tamping device stack, the one or more tamping devicescomprising a rack slidingly disposed about a filament, the filamentbeing connected to the sealing plug. The transferring may furthercomprise automatically unwinding the filament from a spool by deployingan anchor attached to the filament inside the tissue puncture, andwithdrawing the closure device from the tissue puncture. Thetransferring may include driving a gear train meshed with the rack andthe spool via the unwinding.

According to some embodiments, each tamping device of the tamping devicestack comprises a rack. The automatically transducing may then compriserotating a first gear meshed with a magazine feed gear, where thefeeding comprises meshing a first tamping device of the tamping devicestack with the magazine feed gear, moving the first tamping devicelinearly away from the magazine feed gear, urging a second tampingdevice of the tamping device stack laterally toward the magazine feedgear, meshing the second tamping device with the magazine feed gear, andmoving the first and second tamping devices linearly away from themagazine feed gear. The automatically transducing may also compriserotating a first gear meshed with a magazine feed gear, meshing a firsttamping device of the tamping device stack with the magazine feed gear,moving the first tamping device linearly away from the magazine feedgear, meshing the first tamping device with a tamper gear, urging asecond tamping device of the tamping device stack laterally toward themagazine feed gear, meshing the second tamping device with the magazinefeed gear, and moving the first tamping device linearly away from thetamper gear and the second tamping device linearly away from the feedgear.

Another aspect of the invention provides a method of sealing a tissuepuncture in an internal tissue wall accessible through a percutaneousincision. The method comprises providing a tissue puncture closuredevice comprising a filament connected at its distal end to an anchorand to a sealing plug located proximal of the anchor for disposition andanchoring about the tissue puncture, the tissue puncture closure devicealso comprising an automatic magazine fed tamping device, inserting thetissue puncture closure device into the percutaneous incision, deployingthe anchor into the tissue puncture, at least partially withdrawing theclosure device from the percutaneous incision, automatically tamping thesealing plug toward the anchor upon withdrawal of the closure devicefrom the internal tissue wall puncture with the automatic magazine fedtamping device, cutting the filament, and leaving the anchor and thesealing plug at the tissue puncture. The automatically tamping maycomprise biasing a stack of racks toward a magazine feed gear, unwindingthe filament from a spool to rotate the spool, driving a first gear withthe spool, driving the magazine feed gear with the first gear, anddriving two or more racks of the stack toward the sealing plug.

Additional advantages and novel features of the invention will be setforth in the description which follows or may be learned by thoseskilled in the art through reading these materials or practicing theinvention. The advantages of the invention may be achieved through themeans recited in the attached claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate various embodiments of the presentinvention and are a part of the specification. The illustratedembodiments are merely examples of the present invention and do notlimit the scope of the invention.

FIG. 1 is a partial cut-away view of a tissue closure device accordingto the prior art.

FIG. 2 is a side view of the tissue closure device of FIG. 1 engagedwith an artery according to the prior art.

FIG. 3 is a side view of the tissue closure device of FIG. 1 beingwithdrawn from an artery according to the prior art to deploy a collagensponge.

FIG. 4 is a side view of the tissue closure device of FIG. 1illustrating tamping of the collagen sponge according to the prior art.

FIG. 5 is a side view of a tissue closure device with a tamping ordriving mechanism having a magazine fed tamping system, the closuredevice shown engaged with an artery according to one embodiment of thepresent invention.

FIG. 6 is a partial perspective view of one embodiment of the drivingmechanism and magazine of FIG. 5 according to the present invention.

FIG. 7 is a side view of the closure device of FIG. 5 with the devicebeing withdrawn and a sealing plug being automatically tamped accordingto one embodiment of the present invention.

Throughout the drawings, identical reference numbers designate similar,but not necessarily identical, elements.

DETAILED DESCRIPTION

As mentioned above, vascular procedures are conducted throughout theworld and require access to an artery through a puncture. Most often,the artery is a femoral artery. To close the puncture followingcompletion of the procedure, many times a closure device is used tosandwich the puncture between an anchor and a sealing plug. However,sometimes the sealing plug is not properly seated against an exteriorsitus of the arteriotomy. If the plug does not seat against thearteriotomy, there is a potential for elongated bleeding. The presentinvention describes methods and apparatus to reduce or eliminatemovement or misplacement of the sealing plug. While the vascularinstruments shown and described below include insertion sheaths andpuncture sealing devices, the application of principles described hereinare not limited to the specific devices shown. The principles describedherein may be used with any vascular closure device. Therefore, whilethe description below is directed primarily to arterial procedures andcertain embodiments of a vascular closure device, the methods andapparatus are only limited by the appended claims.

As used in this specification and the appended claims, the term “tamp”or “tamping” is used broadly to mean packing down by one or a successionof blows or taps, but not by excessive force. “Engage” and “engageable”are also used broadly to mean interlock, mesh, or contact between twodevices. A “spool” is a cylinder or other device on which something elseis at least partially wound. A “magazine” is any compartment attached toor feeding a machine, used for storing or supplying necessary material.A “rack” is a toothed bar capable of meshing with a gear, wheel, pinion,or other toothed machine part. A “gear train” is a series of two or moreengaged gears. “Urge” or “urging” is used broadly and means to force ordrive forward or onward. A “lumen” refers to any open space or cavity ina bodily organ, especially in a blood vessel. The term “effecting” meansproducing an outcome, achieving a result, or bringing about. A“transducer” is a device capable of converting a force or other inputenergy in one form into output energy or forces of another form ordirection. The words “including” and “having,” as used in thespecification, including the claims, have the same meaning as the word“comprising.”

Referring now to the drawings, and in particular to FIGS. 1-4, avascular puncture closure device 100 is shown according to the priorart. The vascular puncture closure device 100 includes a carrier tube102 with a filament or suture 104 extending at least partiallytherethrough. The closure device 100 also includes a first or proximalend 106 and a second or distal end 107. External to a second or distalend 107 of the carrier tube 102 is an anchor 108. The anchor is anelongated, stiff, low profile member including an eye 109 formed at themiddle. The anchor 108 is typically made of a biologically resorbablepolymer.

The suture 104 is threaded through the anchor 108 and back to a collagenpad 110. The collagen pad 110 may be comprised of randomly orientedfibrous material bound together by chemical means. The collagen pad 110is slidingly attached to the suture 104 as the suture passes distallythrough the carrier tube 102, but as the suture traverses the anchor 108and reenters the carrier tube 102, it is securely slip knotted proximalto the collagen pad 110 to facilitate cinching of the collagen pad 110when the closure device 100 is properly placed and the anchor 108deployed (see FIG. 4).

The carrier tube 102 typically includes a tamping tube 112 disposedtherein. The tamping tube 112 is slidingly mounted on the suture 104 andmay be used by an operator to tamp the collagen pad 110 toward theanchor 108 at an appropriate time to seal a percutaneous tissuepuncture.

Prior to deployment of the anchor 108 within an artery, the eye 109 ofthe anchor 108 rests outside the distal end 107 of the carrier tube 102.The anchor 108 may be temporarily held in place flush with the carriertube 102 by a bypass tube 114 disposed over the distal end 107 of thecarrier tube 102.

The flush arrangement of the anchor 108 and carrier tube 102 allows theanchor 108 to be inserted into an insertion sheath 116 as shown in FIGS.2-4, and eventually through an arterial puncture 118. The insertionsheath 116 is shown in FIGS. 2-4 inserted through a percutaneousincision 119 and into an artery 128. However, the bypass tube 114(FIG. 1) includes an oversized head 120 that prevents the bypass tube114 from passing through an internal passage of the insertion sheath116. Therefore, as the puncture closure device 100 is inserted into theinsertion sheath 116, the oversized head 120 bears against a surface 122of insertion sheath 116. Further insertion of the puncture closuredevice 100 results in sliding movement between the carrier tube 102(FIG. 1) and the bypass tube 114, releasing the anchor 108 from thebypass tube 114 (FIG. 1). However, the anchor 108 remains in the flusharrangement shown in FIG. 1 following release from the bypass tube 114,limited in movement by the insertion sheath 116.

The insertion sheath 116 includes a monofold 124 at a second or distalend 126 thereof. The monofold 124 acts as a one-way valve to the anchor108. The monofold 124 is a plastic deformation in a portion of theinsertion sheath 116 that elastically flexes as the anchor 108 is pushedout through the distal end 126 of the insertion sheath 116. Typically,after the anchor 108 passes through the distal end 126 of the insertionsheath 116 and enters the artery 128, the anchor 108 is no longerconstrained to the flush arrangement with respect to the carrier tube102 and it deploys and rotates to the position shown in FIG. 2.

Referring next to FIGS. 3-4, with the anchor 108 deployed, the punctureclosure device 100 and the insertion sheath 116 are withdrawn together,depositing the collagen pad 110 in the incision tract 119 and exposingthe tamping tube 112. With the tamping tube 112 fully exposed as shownin FIG. 4, the collagen pad 110 is manually tamped, and the anchor 108and collagen pad 110 are cinched together and held in place with theself-tightening slip-knot on the suture 102. Thus, the tissue punctureis sandwiched between the anchor 108 and the collagen pad 110, therebysealing the tissue puncture 118. The suture 104 is then cut and theincision tract 119 may be closed. The suture 104, anchor 108, andcollagen pad 110 are generally made of resorbable materials andtherefore remain in place while the puncture 118 heals.

Using the typical tissue puncture closure device 100 described above,the tamping of the collagen pad 110 cannot commence until the sheath 116has been removed so as to expose the tamping tube 112 for manualgrasping. Under certain conditions, removal of the sheath 116 prior totamping the collagen pad 110 causes the collagen pad 110 to retract fromthe tissue puncture 118, creating a gap 120 between the collagen pad 110and the puncture 118. The gap 120 may remain even after tamping as shownin FIG. 4, and sometimes results in only a partial seal and bleedingfrom the tissue puncture 118.

Therefore, the present specification describes a tissue puncture closuredevice that drives a sealing plug toward a tissue puncture uponwithdrawal of the tissue puncture closure device from the tissuepuncture site. The mechanism for driving the sealing plug is preferablyautomatic and comprises a magazine housing a plurality of separatetamping devices. While the preferred embodiments of the tissue punctureclosure device are shown and described below, the principles of thepresent specification may be incorporated into any of a number of tissueclosure devices. The specific embodiments described below are forillustrative purposes only, and are not limiting.

As described above, the general structure and function of tissue closuredevices used for sealing a tissue puncture in an internal tissue wallaccessible through an incision in the skin are well known in the art.Applications of closure devices including those implementing principlesdescribed herein include closure of a percutaneous puncture or incisionin tissue separating two internal portions of a living body, such aspunctures or incisions in blood vessels, ducts or lumens, gall bladders,livers, hearts, etc.

Referring now to FIG. 5, a closure apparatus, for example an internaltissue puncture closure device 200, is shown according to one embodimentof the present invention. The closure device 200 has particular utilitywhen used in connection with intravascular procedures, such asangiographic dye injection, cardiac catheterization, balloon angioplastyand other types of recanalizing of atherosclerotic arteries, etc. as theclosure device 200 is designed to cause immediate hemostasis of bloodvessel (e.g., arterial) punctures. However, it will be understood thatwhile the description of the preferred embodiments below are directed tothe sealing off of percutaneous punctures in arteries, such devices havemuch more wide-spread applications and can be used for sealing puncturesor incisions in other types of tissue walls as well. Thus, the sealingof a percutaneous puncture in an artery, shown herein, is merelyillustrative of one particular use of the internal tissue closure device200 of the present invention.

The internal tissue closure device 200 includes a handle portion 201 ata first or proximal end 206 and a second or distal end 207. A carriertube 202 extends from the handle portion 201 to the distal end 207. Thecarrier tube 202 may be made of plastic or other material and isdesigned for insertion through a sheath 216, which is designed forinsertion through a percutaneous incision 219 in a tissue layer 230 andinto a lumen 232. According to FIG. 5, the lumen 232 comprises aninterior portion of a femoral artery 228.

At the distal end 207 of the carrier tube 202 there is an anchor 208 anda sealing plug 210. The anchor 208 of the present embodiment is anelongated, stiff, low-profile member arranged to be seated inside theartery 228 against an artery wall 234 contiguous with a puncture 218.The anchor 208 is preferably made of a biologically resorbable polymer.The sealing plug 210 is formed of a compressible sponge, foam, orfibrous mat made of a non-hemostatic biologically resorbable materialsuch as collagen, and may be configured in any shape so as to facilitatesealing the tissue puncture 218.

The sealing plug 210 and anchor 208 are connected to one another by afilament or suture 204 that is also biologically resorbable. The anchor208, the sealing plug 210, and the suture 204 are collectively referredto as the “closure elements” below. As shown in FIG. 5, the anchor 208is arranged adjacent to and exterior of the distal end 207 of the sheath216, while the sealing plug 210 is initially disposed within carriertube 202. Although the anchor 208 is shown deployed with a first surface236 abutting the artery wall 234, it will be understood that initiallythe anchor is arranged axially along the carrier tube 202 to facilitateinsertion into the lumen 232 (see, for example, the anchor 108 of FIG.1). The suture 204 extends distally from the first end 206 of the handleportion 201 and through the carrier tube 202 to the second end 207. Thesuture 204 may be threaded through one or more perforations in thesealing plug 210, through a hole in the anchor 208, and proximally backtoward the carrier tube 202 to the sealing plug 210. Accordingly, thesealing plug 210 is disposed on or slidingly attached to the suture 204at the second end 207 of the tissue puncture closure device 200.

The suture 204 is preferably threaded again through a perforation orseries of perforations in the sealing plug 210. The suture 204 may alsobe threaded around itself to form a self-tightening slip-knot. Thesuture 204 thus connects the anchor 208 and the sealing plug 210 in apulley-like arrangement to cinch the anchor 208 and the sealing plug 210together when the carrier tube 202 is pulled away from the anchor 208and the sealing plug 210, sandwiching and locking the anchor and plugtogether and thereby sealing the tissue puncture 218.

The carrier tube 202 may house a tamping device, such as a tamping tube212, for advancing the sealing plug 210 along the suture 204 and towardthe anchor 208. The tamping tube 212 is shown located within the carriertube 202 and proximal of the sealing plug 210. The tamping tube 212 ispreferably an elongated tubular member that may be rigid or flexible andformed of any suitable material. For example, according to oneembodiment, the tamping tube 212 is made of polyurethane. The suture 204extends through the tamping tube 212 but is not directly connectedthereto. Accordingly, the suture 204 and tamping tube 212 are free toslide past one another. According to the embodiment of FIG. 5, as thesuture 204 extends proximally past the tamping tube 212 and attaches toa driving mechanism 630 located within the handle portion 201 at thefirst end 206 of the closure device 200. One embodiment of the drivingmechanism 630 is described in detail below with reference to FIG. 6.

The tamping tube 212 is shown aligned axially with one or more of aplurality of separate tamping devices, such as a plurality of racks 644,some of which are shown housed in a magazine 640 of the drivingmechanism 630. The racks 644 comprise a magazine fed tamping device andare receptive of gear teeth and discussed in more detail below withreference to FIG. 6. Alternatively, the tamping tube 212 may be omittedand replaced by one or more of the racks 644.

In practice, the carrier tube 202 of the closure device 200 (containingthe closure elements described above) is inserted into the insertionsheath 216, which is shown already inserted within the artery 228.Procedures for placing the insertion sheath 216 within the artery 228are well known to those of skill in the art having the benefit of thisdisclosure. As the closure device 200 and the associated closureelements are inserted into the insertion sheath 216, the anchor 208passes through and out of the distal end of the insertion sheath 216.The anchor 208 is then inserted into the artery lumen 232. As mentionedabove, the anchor 208 is initially arranged substantially parallel withthe carrier tube 202 to facilitate insertion of the anchor 208 throughthe percutaneous incision 219 and into the lumen 232.

Following deployment of the anchor 208 within the lumen 232, the closuredevice 200 is retracted or withdrawn from the insertion sheath 216,which may cause the anchor 208 to catch a monofold at the distal end ofthe insertion sheath 216 and rotate to the position shown in FIG. 5.However, according to some embodiments, the anchor 208 naturally rotatesto the deployed position shown. When resistance to further retraction ofthe closure device 200 is sensed tactilely by an operator, the closuredevice 200 and the insertion sheath 216 are withdrawn together, causingthe anchor 208 to hold fast within the artery 228 against the arterywall 234. With the anchor 208 secured within the artery 228 at thepuncture site 218, further retraction of the closure device 200 andinsertion sheath 216 causes the sealing plug 210 to withdraw from thedistal end 207 of the carrier tube 202, thereby depositing the plug 210within the incision or puncture tract 219 opposite of the anchor 208.

However, unlike previous closure devices that require a separate, manualtamping procedure following the planting of the sealing plug 210, theclosure device 200 of the present invention automatically tamps thesealing plug 210. The closure device 200 drives the tamping tube 212toward the sealing plug 210 automatically upon withdrawal of the closuredevice 200 from the puncture tract 219, tamping the plug 210 toward theanchor 208. Therefore, the sealing plug 210 is tamped while the carriertube 202 is still arranged adjacent to the puncture 218 in the femoralartery 228, reducing or eliminating any gaps that may otherwise occurbetween the sealing plug 210 and the puncture 218 in the femoral artery228.

In addition, by placing tension on or pulling the suture 204 away fromthe puncture tract 219, the suture 204 cinches and locks (with a slipknot or the like) together the anchor 208 and the sealing plug 210,sandwiching the artery wall 234 between the anchor 208 and sealing plug210. The force exerted by the tamping tube 212 and the cinching togetherof the anchor 208 and sealing plug 210 by the filament 204 also causesthe sealing plug 210 to deform radially outward within the puncturetract 219 and function as an anchor on the proximal side of the tissuepuncture site 218.

Automatically driving the tamping tube 212 toward the sealing plug 210and/or cinching the plug and the anchor 208 may be facilitated by any ofa number of mechanisms. For example, a transducer such as the drivingmechanism 630 shown in FIGS. 5-6 may be disposed in the handle portion201 of the closure device 200. According to the embodiment of FIG. 6,retraction of the closure device 200 automatically effects tamping ofthe sealing plug 210 (FIG. 5). A retraction force in a first directionmay be automatically transduced to a tamping force in a second directionas described below. The automatic transducing of the retraction force toa tamping force is achieved, according to FIG. 6, by the drivingmechanism 630 or other transducer.

According to the driving mechanism 630 of FIG. 6, the suture 204 isconnected to and/or partially wound about a spool 632 of a first gearand spool assembly 631. The first gear and spool assembly 631 includesboth the spool 632 and a first or master gear 636. The spool 632 isoperatively connected to the first gear 636 and may be arranged on acommon axis as shown in FIG. 6. According to the embodiment of FIG. 6,the first gear 636 is directly connected to the spool 632, although aclutch between the spool and the first gear 636 may be included to limittorque or disengage the spool 632 from the first gear 636. However, boththe spool 632 and the first gear 636 tend to rotate at the same angularvelocity under normal operating conditions. Withdrawal of the closuredevice 200 (FIG. 5) from the tissue puncture site (if the anchor 208(FIG. 5) is deployed) causes the suture 204 to unwind from the spool632. The spool 632 (and therefore the first gear 636) rotates as thesuture 204 unwinds and provides a torsional motive force that may betransduced to a linear tamping force.

Transducing the torsional motive force provided by the spool 632 to thelinear tamping force is achieved by a gear train 634 according to theembodiment of FIG. 6. The gear train 634 includes the first gear 636arranged coaxially with the spool 632 and a second or magazine feed gear642 meshed with the first gear 636. The gear train 634 may also includea third or tamper gear 643 also meshed with the first gear 636. Thefirst gear 636 drives the second and third gears 642, 643.

According to the embodiment shown in FIG. 6, the suture 204 is wrappedaround the spool 632 in a counter-clockwise manner. Therefore, unwindingthe suture from the spool causes the first gear 636 to rotatecounter-clockwise. The second and third gears 642, 643 thus rotateclockwise. However, according to some embodiments, one or both of thesecond and third gears 642, 643 may be omitted, and the suture may bewound on the spool 632 either clockwise or counter-clockwise, dependingon the desired direction of first gear 636 rotation.

The magazine fed tamping device comprising the plurality of separateracks 644, is disposed adjacent to the second gear 643. Each of theplurality of separate racks 644 is preferably the same size and shape asshown in FIG. 6 and arranged to be fed individually to the gear train634 for substantially linear alignment. Several of the racks 644 areshown stacked in the magazine 640. The racks 644 preferably includetines which mesh with teeth of the second and third gears 642, 643. Atrack 646 may guide the racks 644 as they move out of the magazine 640and distally toward the sealing plug 210 (FIG. 5).

When the spool 632 rotates, the racks 644 are fed by the magazine 640,first to the second gear 642, and then to the third gear 643. As theymove out of the magazine 640, the racks 644 are progressively arrangedlongitudinally and moved distally, abutting and driving the tamping tube212 (FIG. 5), which in turn drives the sealing plug 210 (FIG. 5).Alternatively, the racks 644 may act as a tamping tube itself andtherefore become the “tamping tube 212.”

The racks 644 are preferably semi-tubular and partially able to bedisposed about the suture 204 longitudinally. The semi-tubular shape ofthe racks 644 may have a generally U or V-shaped cross section, andprovide an open channel or trough 648 through which the suture 204 mayenter and exit. The open channel 648 permits the suture 204 and the rack644 to merge as the spool 632 winds or unwinds. The suture 204 and therack 644 are not fixedly connected to one another, allowing each toslide freely past the other. Accordingly, with the anchor 208 (FIG. 5)deployed, as the closure device 200 (FIG. 5) is retracted in a firstdirection, the suture 204 unwinds from the spool 632, which drives thegear train 634. The gear train 634 drives the racks 644 in a second,opposite direction, and the racks 644 drive the tamping tube 212 (FIG.5).

As mentioned above, the stack of racks 644 is housed in a magazine 640.The magazine 640 includes a biasing member such as a spring 650 urgingthe stack of racks 644 in a first direction toward the gear train 634.Therefore, as the gear train 634 rotates, it moves an engaged rack 644distally toward the sealing plug 210 (FIG. 5). When the engaged rack 644clears the extents of the magazine 640, another rack 644 is fed to thegear train 634. Adjacent racks 644 line up longitudinally and drive thetamping tube 212 (FIG. 5) or the sealing plug 210 (FIG. 5) directly.

It may be desirable in some cases to increase the linear velocity of theracks 644 relative to the linear velocity at which the closure device200 (FIG. 5) may be withdrawn. An increased linear velocity for theracks 644 may better assure that the sealing plug 210 (FIG. 5) is forcedtoward the anchor 208 (FIG. 5) while the closure device 200 (FIG. 5) isbeing withdrawn in an opposite direction. Therefore, according to someembodiments, the gear train 634 may have an overall gear ratio greaterthan 1:1. For example, the gear ratio may range between approximately1.5:1 and 3.0:1 for some embodiments, while the gear ratio is about2.1:1 in other embodiments.

However, it should be noted that the linear velocity of the racks 644should not be excessively greater than the linear velocity of withdrawalof the closure device, as excessive speed could potentially force thesealing plug 210 (FIG. 5) through the tissue puncture 218 (FIG. 5) andinto the lumen 232 (FIG. 5) of the artery 228 (FIG. 5). Likewise, aninsufficient opposing force against the anchor 208 (FIG. 5) couldpotentially result in the anchor 208 (FIG. 5) being pulled out of placefrom within the artery 228 (FIG. 5). However, according to some uses,the withdrawal force should not exceed approximately 3.5 pounds.

It will be understood by those of skill in the art having the benefit ofthis disclosure that the drive spool 632 and gear train 634configuration shown in FIG. 6 is exemplary in nature, and not limiting.Any gear configuration may be used to transmit a motive force generatedby retraction of the suture 204 from the closure device 200 (FIG. 5) toprovide an automatic driving force to the sealing plug 210 (FIG. 5) viathe racks 644.

Accordingly, operation of the embodiment of FIGS. 5-7 is as follows. Asthe closing device 200 is retracted from a puncture tract as shown inFIG. 7, the suture 204, which is threaded through the anchor 208,unwinds from and causes rotation of the spool 632. The spool 632 drivesthe first gear 636 as it rotates via the coaxial connection between thespool 632 and the first gear 636. As the first gear 636 rotates, itdrives the second gear 642. The second gear 642 drives one of the racks644 in the magazine 640. The second gear 642 moves the racks 644 towardthe third gear 643, which is also driven by the first gear 636. Thethird gear 643 drives the racks 644 distally, and the racks 644 drivethe tamping tube 212. The tamping tube tamps the sealing plug 210 towardthe anchor 208. Therefore, as the closing device 200 is retracted fromthe puncture tract 219, the sealing plug 210 is automatically tamped viathe driving mechanism 630. The sealing plug 210 is more likely to createa sufficient arterial seal without gaps between the sealing plug 210 andthe anchor 208, as may otherwise occur with a separate manual tampingprocedure. Following tamping, the suture 204 may be cut and the anchor208, the sealing plug 210, and the portion of the suture 204 extendingtherebetween remain, sealing the puncture 218. Moreover, the magazine640 facilitates a compact device for tamping the sealing plug 210.

The preceding description has been presented only to illustrate anddescribe exemplary embodiments of invention. It is not intended to beexhaustive or to limit the invention to any precise form disclosed. Manymodifications and variations are possible in light of the aboveteaching. It is intended that the scope of the invention be defined bythe following claims.

1. An internal tissue puncture closure device, comprising: a filamentextending from a first end of the closure device to a second end of theclosure device; an anchor for insertion through the tissue wall punctureattached to the filament at the second end of the closure device; asealing plug slidingly attached to the filament adjacent to the anchor;a driving mechanism for tamping the sealing plug toward the second end,the driving mechanism comprising a magazine housing a plurality ofseparate tamping devices.
 2. An internal tissue puncture closure deviceaccording to claim 1 wherein the plurality of separate tamping deviceseach comprise a rack.
 3. An internal tissue puncture closure deviceaccording to claim 1 wherein the magazine comprises a biasing member,and wherein the plurality of separate tamping devices are stacked in themagazine and biased in a first direction by the biasing member.
 4. Aninternal tissue puncture closure device according to claim 1 wherein thedriving mechanism comprises a transducer capable of effecting a distalforce on one or more of the plurality of separate tamping devices uponwithdrawal of at least a portion of the closure device from a tissuepuncture.
 5. An internal tissue puncture closure device according toclaim 1 wherein the driving mechanism comprises: a transducer capable ofeffecting a distal force on one or more of the plurality of separatetamping devices upon withdrawal of at least a portion of the closuredevice from a tissue puncture, the transducer comprising: a first gearand spool assembly with a portion of the filament wound on the spool;wherein one or more of the plurality of tamping devices is directly orindirectly driven by the first gear.
 6. An internal tissue punctureclosure device according to claim 1 wherein the driving mechanismcomprises: a transducer capable of effecting a distal force on one ormore of the plurality of separate tamping devices upon withdrawal of atleast a portion of the closure device from a tissue puncture, thetransducer comprising: a first gear and spool assembly with a portion ofthe filament wound on the spool, the first gear and spool assemblydisposed on a common axis and interconnected; a second gear meshed withthe first gear; wherein one or more of the plurality of tamping devicesis directly driven linearly by the second gear.
 7. An internal tissuepuncture closure device according to claim 1 wherein the drivingmechanism comprises: a transducer capable of effecting a distal force onone or more of the plurality of separate tamping devices upon withdrawalof at least a portion of the closure device from a tissue puncture, thetransducer comprising: a first gear and spool assembly with a portion ofthe filament wound on the spool, the first gear and spool assemblydisposed on a common axis and interconnected; a second gear meshed withthe first gear; a third gear meshed with the first gear; wherein one ormore of the plurality of tamping devices is directly driven linearly bythe second and third gears.
 8. An internal tissue puncture closuredevice according to claim 1, further comprising a tamping tube slidinglydisposed about the filament adjacent to the sealing plug; wherein thedriving mechanism comprises: a transducer capable of effecting a distalforce on one or more of the plurality of separate tamping devices uponwithdrawal of at least a portion of the closure device from a tissuepuncture, the transducer comprising: a first gear and spool assemblywith a portion of the filament wound on the spool, the first gear andspool assembly disposed on a common axis and interconnected; a secondgear meshed with the first gear; wherein one or more of the plurality oftamping devices is directly driven linearly by the second gear; whereinthe one or more of the plurality of tamping devices abuts and drives thetamping tube and the sealing plug toward the anchor.
 9. An internaltissue puncture closure device according to claim 1 wherein the drivingmechanism comprises: a transducer capable of effecting a distal force onone or more of the plurality of separate tamping devices upon withdrawalof at least a portion of the closure device from a tissue puncture, thetransducer comprising: a first gear and spool assembly with a portion ofthe filament wound on the spool, the first gear and spool assemblydisposed on a common axis and interconnected; a magazine feed gearmeshed with the first gear; a tamper gear meshed with the first gear;wherein one or more of the plurality of tamping devices is fed by themagazine feed gear to the tamper gear and driven by the tamper gear totamp the sealing plug toward the anchor.
 10. An internal tissue punctureclosure device according to claim 1, further comprising a tamping tubedisposed adjacent to the sealing plug; wherein the drive mechanismcomprises an automatic driving mechanism; wherein the plurality oftamping devices is driven by the automatic driving mechanism in responseto retraction of the closure devices; wherein the tamping tube is drivenby the plurality of tamping devices to tamp the sealing plug.
 11. Aninternal tissue puncture closure device according to claim 1, furthercomprising a tamping tube disposed adjacent to the sealing plug; whereinthe tamping tube is driven by the driving mechanism to tamp the sealingplug; wherein the driving mechanism comprises a transducer for effectinga tamping force on the sealing plug upon withdrawal of the closuredevice from the tissue wall puncture; wherein the transducer comprises:a first gear and spool assembly with a portion of the filament woundthereon; one or more of the plurality of tamping devices directly orindirectly driven by the first gear; wherein the spool rotates anddrives the first gear in a first direction, and the first gear drivesone or more of the plurality of tamping devices in a second direction,when the anchor is deployed and the closure device is retracted from thetissue wall puncture.
 12. A tissue puncture closure device for partialinsertion into and sealing of a tissue puncture in an internal tissuewall accessible through a percutaneous incision, comprising a handleportion; a carrier tube extending from the handle portion; a filamentextending from the from the handle portion and through the carrier tube;a sealing plug disposed on the filament; a gear train housed in thehandle portion; a spool operatively connected to the gear train; aportion of the filament wound on the spool; a magazine fed tampingdevice operatively connected to the gear train.
 13. A tissue punctureclosure device for partial insertion into and sealing of a tissuepuncture in an internal tissue wall accessible through a percutaneousincision according to claim 12 wherein the spool is coaxial with andconnected to one gear of the gear train.
 14. A tissue puncture closuredevice for partial insertion into and sealing of a tissue puncture in aninternal tissue wall accessible through a percutaneous incisionaccording to claim 12 wherein the magazine fed tamping device comprisesa spring loaded set of stacked racks engagable with the gear train. 15.A tissue puncture closure device for partial insertion into and sealingof a tissue puncture in an internal tissue wall accessible through apercutaneous incision according to claim 12 wherein the gear traincomprises a master gear and two slave gears each meshed with the mastergear.
 16. A tissue puncture closure device for partial insertion intoand sealing of a tissue puncture in an internal tissue wall accessiblethrough a percutaneous incision according to claim 12, furthercomprising an anchor attached to the filament at a distal end of thecarrier tube, wherein the filament unwinds from the spool and drives thegear train in response to retraction of the handle portion from thetissue puncture if the anchor is deployed therein; wherein the geartrain automatically drives the magazine fed tamping device; wherein themagazine fed tamping device tamps the sealing plug toward the anchor.17. A method of sealing a tissue puncture in an internal tissue wallaccessible through a percutaneous incision, comprising: withdrawing aclosure device from the tissue puncture; feeding a tamping device stackto a tranducer; automatically transducing a motive force generated bywithdrawal of the closure device in a first direction to a tamping forceon the tamping device stack in a second direction.
 18. A method ofsealing a tissue puncture in an internal tissue wall accessible througha percutaneous incision according to claim 17 wherein the feedingfurther comprises biasing the tamping device stack with a spring in amagazine housing the tamping device stack.
 19. A method of sealing atissue puncture in an internal tissue wall accessible through apercutaneous incision according to claim 17, further comprising applyingthe tamping force in the second direction to a sealing plug.
 20. Amethod of sealing a tissue puncture in an internal tissue wallaccessible through a percutaneous incision according to claim 17,further comprising: applying the tamping force in the second directionto a sealing plug; transferring the motive force to one or more tampingdevices of the tamping device stack, the one or more tamping devicescomprising a rack slidingly disposed about a filament, the filamentbeing connected to a sealing plug.
 21. A method of sealing a tissuepuncture in an internal tissue wall accessible through a percutaneousincision according to claim 17, further comprising: applying the tampingforce in the second direction to a sealing plug; transferring the motiveforce to one or more tamping devices of the tamping device stack, theone or more tamping devices comprising a rack slidingly disposed about afilament, the filament being connected to a sealing plug; wherein thetransferring further comprises automatically unwinding the filament froma spool by deploying an anchor attached to the filament inside thetissue puncture, and withdrawing the closure device from the tissuepuncture.
 22. A method of sealing a tissue puncture in an internaltissue wall accessible through a percutaneous incision according toclaim 17, further comprising: applying the tamping force in the seconddirection to a sealing plug; transferring the motive force to one ormore tamping devices of the tamping device stack, the one or moretamping devices comprising a rack slidingly disposed about a filament,the filament being connected to a sealing plug; wherein the transferringfurther comprises automatically unwinding the filament from a spool bydeploying an anchor attached to the filament inside the tissue puncture,and withdrawing the closure device from the tissue puncture; wherein thetransferring further comprises driving a gear train meshed with the rackand the spool via the unwinding.
 23. A method of sealing a tissuepuncture in an internal tissue wall accessible through a percutaneousincision according to claim 17 wherein each tamping device of thetamping device stack comprises a rack; wherein the automaticallytransducing comprises rotating a first gear meshed with a magazine feedgear; wherein the feeding comprises: meshing a first tamping device ofthe tamping device stack with the magazine feed gear; moving the firsttamping device linearly away from the magazine feed gear; urging asecond tamping device of the tamping device stack laterally toward themagazine feed gear; meshing the second tamping device with the magazinefeed gear; moving the first and second tamping devices linearly awayfrom the magazine feed gear.
 24. A method of sealing a tissue puncturein an internal tissue wall accessible through a percutaneous incisionaccording to claim 17 wherein each tamping device of the tamping devicestack comprises a rack; wherein the automatically transducing comprisesrotating a first gear meshed with a magazine feed gear and a tampergear; wherein the feeding comprises: meshing a first tamping device ofthe tamping device stack with the magazine feed gear; moving the firsttamping device linearly away from the magazine feed gear; meshing thefirst tamping device with the tamper gear; urging a second tampingdevice of the tamping device stack laterally toward the magazine feedgear; meshing the second tamping device with the magazine feed gear;moving the first tamping device linearly away from the tamper gear andthe second tamping device linearly away from the feed gear.
 25. A methodof sealing a tissue puncture in an internal tissue wall accessiblethrough a percutaneous incision, comprising: providing a tissue punctureclosure device comprising a filament connected at its distal end to ananchor and to a sealing plug located proximal of the anchor fordisposition and anchoring about the tissue puncture, the tissue punctureclosure device also comprising an automatic magazine fed tamping device;inserting the tissue puncture closure device into the percutaneousincision; deploying the anchor into the tissue puncture; at leastpartially withdrawing the closure device from the percutaneous incision;automatically tamping the sealing plug toward the anchor upon withdrawalof the closure device from the internal tissue wall puncture with theautomatic magazine fed tamping device; cutting the filament; leaving theanchor and the sealing plug at the tissue puncture.
 26. A method ofsealing a tissue puncture in an internal tissue wall accessible througha percutaneous incision according to claim 25 wherein the automaticmagazine fed tamping device comprises a stack of racks biased toward amagazine feed gear.
 27. A method of sealing a tissue puncture in aninternal tissue wall accessible through a percutaneous incisionaccording to claim 25 wherein the automatically tamping comprises:biasing a stack of racks toward a magazine feed gear; unwinding thefilament from a spool to rotate the spool; driving a first gear with thespool; driving the magazine feed gear with the first gear; driving twoor more racks of the stack toward the sealing plug.